CN1634045A - 复方法莫替丁咀嚼片制备方法 - Google Patents
复方法莫替丁咀嚼片制备方法 Download PDFInfo
- Publication number
- CN1634045A CN1634045A CN 200310122940 CN200310122940A CN1634045A CN 1634045 A CN1634045 A CN 1634045A CN 200310122940 CN200310122940 CN 200310122940 CN 200310122940 A CN200310122940 A CN 200310122940A CN 1634045 A CN1634045 A CN 1634045A
- Authority
- CN
- China
- Prior art keywords
- famotidine
- preparation
- binding agent
- coating
- correctives
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- XUFQPHANEAPEMJ-UHFFFAOYSA-N famotidine Chemical compound NC(N)=NC1=NC(CSCCC(N)=NS(N)(=O)=O)=CS1 XUFQPHANEAPEMJ-UHFFFAOYSA-N 0.000 title claims abstract description 58
- 229960001596 famotidine Drugs 0.000 title claims abstract description 58
- 238000002360 preparation method Methods 0.000 title claims abstract description 35
- 230000001055 chewing effect Effects 0.000 title claims abstract description 15
- 150000001875 compounds Chemical class 0.000 title claims abstract description 15
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims abstract description 29
- 229910000019 calcium carbonate Inorganic materials 0.000 claims abstract description 14
- VTHJTEIRLNZDEV-UHFFFAOYSA-L magnesium dihydroxide Chemical compound [OH-].[OH-].[Mg+2] VTHJTEIRLNZDEV-UHFFFAOYSA-L 0.000 claims abstract description 14
- 239000000347 magnesium hydroxide Substances 0.000 claims abstract description 14
- 229910001862 magnesium hydroxide Inorganic materials 0.000 claims abstract description 14
- 238000005469 granulation Methods 0.000 claims abstract description 7
- 230000003179 granulation Effects 0.000 claims abstract description 7
- 238000000576 coating method Methods 0.000 claims description 16
- 238000000034 method Methods 0.000 claims description 16
- 239000011248 coating agent Substances 0.000 claims description 15
- 239000000203 mixture Substances 0.000 claims description 15
- 239000008187 granular material Substances 0.000 claims description 14
- -1 polyethylene pyrrole Polymers 0.000 claims description 13
- 239000003826 tablet Substances 0.000 claims description 13
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical group [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 12
- 239000007931 coated granule Substances 0.000 claims description 11
- 229920002472 Starch Polymers 0.000 claims description 10
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 10
- 229930006000 Sucrose Natural products 0.000 claims description 10
- 239000011230 binding agent Substances 0.000 claims description 10
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 10
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 10
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 10
- 239000002245 particle Substances 0.000 claims description 10
- 239000008107 starch Substances 0.000 claims description 10
- 235000019698 starch Nutrition 0.000 claims description 10
- 239000005720 sucrose Substances 0.000 claims description 10
- GUBGYTABKSRVRQ-QKKXKWKRSA-N lactose group Chemical group OC1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@@H](O)[C@H](O2)CO)[C@H](O1)CO GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 9
- 239000000463 material Substances 0.000 claims description 9
- 108010011485 Aspartame Proteins 0.000 claims description 8
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 8
- 229930195725 Mannitol Natural products 0.000 claims description 8
- 239000000605 aspartame Substances 0.000 claims description 8
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 claims description 8
- 235000010357 aspartame Nutrition 0.000 claims description 8
- 229960003438 aspartame Drugs 0.000 claims description 8
- 239000008101 lactose Substances 0.000 claims description 8
- 239000000594 mannitol Substances 0.000 claims description 8
- 235000010355 mannitol Nutrition 0.000 claims description 8
- 239000004094 surface-active agent Substances 0.000 claims description 7
- 239000001856 Ethyl cellulose Substances 0.000 claims description 6
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims description 6
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical group [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims description 6
- 239000004141 Sodium laurylsulphate Substances 0.000 claims description 6
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 claims description 6
- 235000019325 ethyl cellulose Nutrition 0.000 claims description 6
- 229920001249 ethyl cellulose Polymers 0.000 claims description 6
- 239000000314 lubricant Substances 0.000 claims description 6
- 235000019359 magnesium stearate Nutrition 0.000 claims description 6
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 6
- 229920000053 polysorbate 80 Polymers 0.000 claims description 6
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims description 6
- 241000207199 Citrus Species 0.000 claims description 5
- 235000020971 citrus fruits Nutrition 0.000 claims description 5
- 229960001855 mannitol Drugs 0.000 claims description 5
- 229960004793 sucrose Drugs 0.000 claims description 5
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 4
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 4
- UEDUENGHJMELGK-HYDKPPNVSA-N Stevioside Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1O[C@]12C(=C)C[C@@]3(C1)CC[C@@H]1[C@@](C)(CCC[C@]1([C@@H]3CC2)C)C(=O)O[C@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O UEDUENGHJMELGK-HYDKPPNVSA-N 0.000 claims description 4
- 239000003085 diluting agent Substances 0.000 claims description 4
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 4
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 4
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 4
- 229940013618 stevioside Drugs 0.000 claims description 4
- OHHNJQXIOPOJSC-UHFFFAOYSA-N stevioside Natural products CC1(CCCC2(C)C3(C)CCC4(CC3(CCC12C)CC4=C)OC5OC(CO)C(O)C(O)C5OC6OC(CO)C(O)C(O)C6O)C(=O)OC7OC(CO)C(O)C(O)C7O OHHNJQXIOPOJSC-UHFFFAOYSA-N 0.000 claims description 4
- 235000019202 steviosides Nutrition 0.000 claims description 4
- 239000002202 Polyethylene glycol Substances 0.000 claims description 3
- 229920001223 polyethylene glycol Polymers 0.000 claims description 3
- MEIRRNXMZYDVDW-MQQKCMAXSA-N (2E,4E)-2,4-hexadien-1-ol Chemical compound C\C=C\C=C\CO MEIRRNXMZYDVDW-MQQKCMAXSA-N 0.000 claims description 2
- 229920001353 Dextrin Polymers 0.000 claims description 2
- 239000004375 Dextrin Substances 0.000 claims description 2
- 239000007910 chewable tablet Substances 0.000 claims description 2
- 229940068682 chewable tablet Drugs 0.000 claims description 2
- 235000019425 dextrin Nutrition 0.000 claims description 2
- 238000004033 diameter control Methods 0.000 claims description 2
- 229960003943 hypromellose Drugs 0.000 claims description 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 2
- 239000000843 powder Substances 0.000 claims description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 2
- 238000002156 mixing Methods 0.000 abstract description 2
- 239000002671 adjuvant Substances 0.000 abstract 1
- 238000005453 pelletization Methods 0.000 abstract 1
- 238000005516 engineering process Methods 0.000 description 9
- 238000009835 boiling Methods 0.000 description 8
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 description 8
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 7
- 229960001375 lactose Drugs 0.000 description 7
- 239000003814 drug Substances 0.000 description 6
- 201000010099 disease Diseases 0.000 description 5
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 5
- 229940079593 drug Drugs 0.000 description 5
- 239000003795 chemical substances by application Substances 0.000 description 4
- 239000003086 colorant Substances 0.000 description 3
- 201000006549 dyspepsia Diseases 0.000 description 3
- 210000001035 gastrointestinal tract Anatomy 0.000 description 3
- 239000007921 spray Substances 0.000 description 3
- 238000005507 spraying Methods 0.000 description 3
- 229910001220 stainless steel Inorganic materials 0.000 description 3
- 239000010935 stainless steel Substances 0.000 description 3
- 238000005303 weighing Methods 0.000 description 3
- 239000002253 acid Substances 0.000 description 2
- 235000012730 carminic acid Nutrition 0.000 description 2
- 208000024798 heartburn Diseases 0.000 description 2
- 239000012535 impurity Substances 0.000 description 2
- 206010025482 malaise Diseases 0.000 description 2
- 239000002002 slurry Substances 0.000 description 2
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 description 1
- 208000017667 Chronic Disease Diseases 0.000 description 1
- 244000248349 Citrus limon Species 0.000 description 1
- 235000005979 Citrus limon Nutrition 0.000 description 1
- 208000012895 Gastric disease Diseases 0.000 description 1
- 208000008469 Peptic Ulcer Diseases 0.000 description 1
- 229940069428 antacid Drugs 0.000 description 1
- 239000003159 antacid agent Substances 0.000 description 1
- 230000001458 anti-acid effect Effects 0.000 description 1
- 235000019658 bitter taste Nutrition 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 235000012343 cottonseed oil Nutrition 0.000 description 1
- 208000010643 digestive system disease Diseases 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 206010016766 flatulence Diseases 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 230000027119 gastric acid secretion Effects 0.000 description 1
- 238000004811 liquid chromatography Methods 0.000 description 1
- 229940112989 pepcid complete Drugs 0.000 description 1
- 208000011906 peptic ulcer disease Diseases 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 229940093429 polyethylene glycol 6000 Drugs 0.000 description 1
- 238000002203 pretreatment Methods 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 230000000630 rising effect Effects 0.000 description 1
- 229940032147 starch Drugs 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 208000018556 stomach disease Diseases 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
考验条件 | 未包衣(含量%) | 包衣(含量%) |
原始样品 | 99.56 | 100.15 |
40℃,RH75%,六个月 | 75.53 | 99.56 |
总杂质 | 5.89 | 0.98 |
批号 | 1 | 2 | 3 |
均匀度(法莫替丁) | 8.53 | 7.65 | 7.85 |
成份 | 处方1 |
法莫替丁 | 10g |
吐温-80 | 20g |
阿斯巴甜 | 2g |
羟丙甲基纤维素 | 5g |
成份 | 处方2 |
法莫替丁 | 10g |
十二烷基硫酸钠 | 2g |
阿斯巴甜 | 1g |
羟丙甲基纤维素 | 1.5g |
成份 | 处方4 |
法莫替丁 | 10g |
十二烷基硫酸钠 | 4g |
蔗糖 | 50g |
乙基纤维素 | 17g |
聚乙稀吡洛烷酮 | 10g |
成份 | 处方5 |
法莫替丁 | 10g |
十二烷基硫酸钠 | 4g |
蔗糖 | 100g |
乙基纤维素 | 10g |
吐温-80 | 20g |
Claims (8)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CNB200310122940XA CN100506226C (zh) | 2003-12-31 | 2003-12-31 | 复方法莫替丁咀嚼片制备方法 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CNB200310122940XA CN100506226C (zh) | 2003-12-31 | 2003-12-31 | 复方法莫替丁咀嚼片制备方法 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1634045A true CN1634045A (zh) | 2005-07-06 |
CN100506226C CN100506226C (zh) | 2009-07-01 |
Family
ID=34844685
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CNB200310122940XA Expired - Lifetime CN100506226C (zh) | 2003-12-31 | 2003-12-31 | 复方法莫替丁咀嚼片制备方法 |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN100506226C (zh) |
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN100450481C (zh) * | 2006-06-28 | 2009-01-14 | 苏州东瑞制药有限公司 | 含法莫替丁-环糊精包合物的复方药物组合物及其制备方法 |
CN100493499C (zh) * | 2005-10-14 | 2009-06-03 | 四川泰华堂制药有限公司 | 制备复方法莫替丁咀嚼片的方法 |
CN104906057A (zh) * | 2015-05-29 | 2015-09-16 | 西南药业股份有限公司 | 法莫替丁钙镁微丸型咀嚼片的制备方法及其产品 |
CN104971073A (zh) * | 2015-05-29 | 2015-10-14 | 西南药业股份有限公司 | 法莫替丁钙镁咀嚼片的制备方法及其产品 |
CN112294841A (zh) * | 2020-10-21 | 2021-02-02 | 北京鑫开元医药科技有限公司 | 一种法莫替丁枸橼酸铋钾复方组合物、制备方法及其应用 |
CN113143876A (zh) * | 2020-12-30 | 2021-07-23 | 河南合智医药科技有限公司 | 一种稳定的复方法莫替丁咀嚼片及其制备方法 |
Family Cites Families (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5989588A (en) * | 1996-10-04 | 1999-11-23 | Merck & Co., Inc. | Methods and compositions for preventing and treating heartburn |
-
2003
- 2003-12-31 CN CNB200310122940XA patent/CN100506226C/zh not_active Expired - Lifetime
Cited By (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN100493499C (zh) * | 2005-10-14 | 2009-06-03 | 四川泰华堂制药有限公司 | 制备复方法莫替丁咀嚼片的方法 |
CN100450481C (zh) * | 2006-06-28 | 2009-01-14 | 苏州东瑞制药有限公司 | 含法莫替丁-环糊精包合物的复方药物组合物及其制备方法 |
CN104906057A (zh) * | 2015-05-29 | 2015-09-16 | 西南药业股份有限公司 | 法莫替丁钙镁微丸型咀嚼片的制备方法及其产品 |
CN104971073A (zh) * | 2015-05-29 | 2015-10-14 | 西南药业股份有限公司 | 法莫替丁钙镁咀嚼片的制备方法及其产品 |
CN104971073B (zh) * | 2015-05-29 | 2018-01-12 | 西南药业股份有限公司 | 法莫替丁钙镁咀嚼片的制备方法及其产品 |
CN104906057B (zh) * | 2015-05-29 | 2018-03-02 | 西南药业股份有限公司 | 法莫替丁钙镁微丸型咀嚼片的制备方法及其产品 |
CN112294841A (zh) * | 2020-10-21 | 2021-02-02 | 北京鑫开元医药科技有限公司 | 一种法莫替丁枸橼酸铋钾复方组合物、制备方法及其应用 |
CN113143876A (zh) * | 2020-12-30 | 2021-07-23 | 河南合智医药科技有限公司 | 一种稳定的复方法莫替丁咀嚼片及其制备方法 |
Also Published As
Publication number | Publication date |
---|---|
CN100506226C (zh) | 2009-07-01 |
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Owner name: SHANGHAI SINE PHARMACEUTICAL FACTORY CO., LTD. Free format text: FORMER NAME: SINE PHARMACY FACTORY |
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Address after: No. 905 Jinqiao Road, Shanghai, Pudong New Area Patentee after: SHANGHAI SINE PHARMACEUTICAL Co.,Ltd. Address before: No. 905 Jinqiao Road, Shanghai, Pudong New Area Patentee before: Xinyi Pharmaceutical Factory |
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CP01 | Change in the name or title of a patent holder |
Address after: 201206 Pudong New Area new Jinqiao Road, Shanghai, No. 905 Patentee after: SPH SINE PHARMACEUTICAL LABORATORIES Co.,Ltd. Address before: 201206 Pudong New Area new Jinqiao Road, Shanghai, No. 905 Patentee before: SHANGHAI SINE PHARMACEUTICAL Co.,Ltd. |
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Granted publication date: 20090701 |